Saline Flush Syringe RFQ Checklist: What to Specify Before You Request a Quote

By Kevin Leoncio, Account Representative, Essential Cares Supplies, Inc.

A quote request that reads "saline flush, 10 mL, 30 boxes" can come back as three different products at three different unit prices. One supplier quotes a 10 mL syringe holding 10 mL of saline, another quotes a 12 mL syringe filled to 10 mL, and a third quotes by the case without saying how many syringes are in it. None of them is wrong. The request just left out the fields that decide what you are actually buying.

This checklist is for the person writing the RFQ. It lists the fields to put on a saline flush quote request, why each one matters, and how to read the answers. For background on what prefilled flush syringes are and how facilities buy them, start with the prefilled saline flush syringes purchasing guide. This article assumes you already know what you need and want the quote to come back comparable.

Why saline flush RFQs come back uncomparable

Four things cause most of the trouble:

• Fill volume and syringe size are different numbers. A listing that says "10ml" may be describing the fluid, the barrel, or both.
• Unit of measure. One price may be per syringe, another per box, another per case, and the box and case counts differ between items.
• Manufacturer number versus distributor SKU. The part number a distributor uses internally is not always the number printed on the manufacturer's carton.
• Silence on dating and substitutions. If the RFQ does not say how much shelf life must remain at delivery, or whether substitutes are allowed, the quote will not either.

The RFQ field checklist

Copy the fields below into your request. Where you have a current item in use, take the values from its carton or label, not from memory or an invoice description.

Fill volume is not syringe size

FDA 510(k) summaries for prefilled saline flush syringes from different manufacturers show the pattern clearly. Each of the three we reviewed describes the product in 3 mL, 5 mL and 10 mL fill volumes that share a single 10 mL syringe barrel. In other words, the fill is a variable inside a fixed syringe. These summaries are cited as examples of how the category is documented; they are not records for the items in the table below. One of them says the larger barrel diameter was chosen to limit the pressure generated during use.

ECSI's own listings show the same distinction in the other direction. Two items are named "10ml fill in 12ml syringe": the Normal Saline IV Flush 10ml fill in 12ml syringe and a Nurse Assist 1210-BP listing. Other items on the site are named simply "10ml." If your specification says "10 mL saline flush," a supplier cannot tell from those words whether a 10 mL syringe or a 12 mL syringe is acceptable. Write both numbers.

Listed pack configurations

The table below lists five saline flush items shown on the ECSI site, with the pack structure as stated in each product name. It is a list of configurations, not a statement that any two items are interchangeable. The listing pages we reviewed do not state sterility, latex or DEHP wording. Verify every specification against the manufacturer's labeling for the item you intend to buy.

Three things to read from the table. First, three items are named "10ml" without saying whether that is the fill, the barrel, or both, so they need that question answered before they can be compared with anything. Second, the per-case totals range from 180 to 400, so a quote by the case cannot be compared with another without dividing out. Third, the last row's name gives a case total but not a box count, and its listing page shows unit-of-measure options that do not clearly state how many syringes are in a box. Confirm what "case" means on that item before you convert its price.

Also note that the SKU field on these listings is not the same string as the part number in the product name (SS1010 versus MSYRSS1010ES, for example). That is normal for a distributor, and it is the reason the next section matters.

Manufacturer number versus distributor SKU

A distributor SKU identifies a line in that distributor's catalog. A manufacturer part number identifies the product the manufacturer makes. For a saline flush RFQ, put the manufacturer part number in the request, and treat the distributor SKU as the supplier's own reference. When a supplier answers with a SKU only, ask for the manufacturer name and number it maps to. The medical supply RFQ checklist covers this for supplies in general.

Cost per syringe: an illustrative example

The numbers below are hypothetical and chosen only to show the arithmetic. They are not ECSI prices.

• Quote A: $120.00 per case, 240 syringes per case (30 per box, 8 boxes). Cost per syringe = $120 / 240 = $0.50.
• Quote B: $100.00 per case, 180 syringes per case (30 per box, 6 boxes). Cost per syringe = $100 / 180 = about $0.56.

Quote B has the lower case price and the higher cost per syringe. If the two items also differ in fill volume or syringe size, the per-syringe number still does not make them the same product. Use it for budgeting, then decide on specification first. The UOM and case-pack conversion guide goes through the full conversion method.

Dating, lots and substitutions

Shelf life is a manufacturer-stated attribute, and it is set by the manufacturer for each product. One FDA 510(k) summary we reviewed states a one-year shelf life based on a real-time aging study. Do not assume the same figure for another item. Ask for the dating of the specific item and set a minimum remaining shelf life on the RFQ, for example "no less than X months remaining on the date of delivery." Pick a number that matches how fast your facility actually uses the product.

For lots, ask that the lot number and expiry be visible on boxes and cases and that lot information appear on the packing slip. That makes a receiving check possible and makes any later lookup straightforward.

For substitutions, write the rule down. Two workable versions are "no substitutions without written approval from our purchasing department" and "a substitute may be proposed with the manufacturer, part number, specification and documentation, and is not shipped until approved." The product equivalency and substitution checklist describes how to sort a proposed substitute into exact match, functional alternative, potential substitute or different product.

What the regulatory record can and cannot tell you

The three FDA 510(k) summaries we reviewed list prefilled saline flush syringes as devices under 21 CFR 880.5200 ("Intravascular catheter"), Class II, product code NGT. One states the indication as flushing compatible intravenous administration sets and indwelling intravenous access devices. They also describe sterilization in different terms (steam, gamma radiation, moist heat) and, in one case, state that the device is not made with natural rubber latex. A summary that does not mention latex is not a latex-free statement.

The point for procurement: these documents belong to specific products. Whether a particular item you are quoting has a 510(k), and what its labeling says, has to come from that item's manufacturer. Ask for it by name on the RFQ.

Common mistakes

• Writing "10 mL" without saying whether it is fill or barrel.
• Comparing a per-box price to a per-case price.
• Accepting a distributor SKU in place of a manufacturer part number.
• Leaving out minimum remaining shelf life, then finding short-dated stock at receiving.
• Asking a supplier to "confirm it is latex-free" instead of requesting the manufacturer's written statement.
• Not stating the substitution rule, then discovering a different product after the order shipped.

Sample RFQ wording

Related ECSI Resources

Frequently Asked Questions

Sources

• FDA 510(k) clearance letter and summary, Hantech pre-filled 0.9% normal saline flush syringes (K231363): regulation 21 CFR 880.5200, Class II, product code NGT; indications; 3, 5 and 10 mL fills in a 10 mL barrel; stated shelf life.
• FDA 510(k) clearance letter and summary, PentaFlush prefilled saline syringe (K214080): same regulation and product code; fills in 10 mL syringes; gamma sterilization; natural rubber latex statement.
• FDA 510(k) summary, BD PosiFlush SP syringe (K161552): same regulation and product code; 3, 5 and 10 mL fills on a common 10 mL barrel; moist heat sterilization.